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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
27/09/2004
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr. Kirit Ardeshna
Recruitment target:
484
EudraCT number:
2004-001621-16
Contact details:
ctc.watchandwait@ucl.ac.uk
Lay summary:
Watch & Wait
An intergroup randomised trial of rituximab versus a watch and wait strategy in patients with advanced stage, asymptomatic, non-bulky follicular lymphoma (Grades 1, 2 and 3a)
Description
Design: The Watch and Wait study is a randomised phase III trial to determine whether giving treatment with rituximab to patients with advanced stage asymptomatic follicular lymphoma (grades 1, 2 and 3a) results in a significant delay in the initiation of chemotherapy or radiotherapy compared to the standard “watch and wait” approach, and the impact of each strategy on patients’ quality of life.
Treatment: Patients will be randomised to receive either rituximab weekly for 4 weeks followed by 2 years of rituximab maintenance given every 8 weeks, or to a watch and wait policy.  Patients will then be followed up every 2 months for a further 2 years and then annually thereafter. Patients will complete quality of life questionnaires at randomisation then every 2 months.
Key inclusion/exclusion criteria: Patients must be aged 18 or over and have histologically proven follicular lymphoma grade 1, 2 and 3a.  Patient must have stage II-IV disease and be asymptomatic without B symptoms or severe pruritus.  Patients ECOG performance status must be 0-1 and they must have low tumour burden. Patients who are HIV positive or have hepatitis B infection are not eligible for the trial.
Duration of recruitment: 4 years
Aim
The aim of the Watch and Wait trial is to investigate whether rituximab can significantly delay the time to initiation of chemotherapy or radiotherapy in patients with newly-diagnosed, asymptomatic follicular lymphoma, and to explore the impact of this strategy on patients’ quality of life compared with a watchful waiting approach.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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